Research Associate (m/f/d) Quality Control Biology - Biochemistry & Serology (Chemist)

Purpose of the Position

You ensure the quality and timely testing of medicinal products and vaccines, intermediates, as well as starting and excipient materials in accordance with pharmaceutical law requirements, and are responsible for the GMP-compliant implementation of new testing methods into routine analysis. As a technical contact person, you will lead laboratory personnel and represent your topics to customers and authorities.

Your Tasks

• Creation and revision of specification documents (SOPs, testing methods, Work Instructions) as well as planning and report documents for method developments, transfers, verifications, and validations
• Technical guidance of laboratory technicians in method projects, including monitoring of the generated data and derivation of necessary adjustments
• Completion of testing documentation for samples, reference materials, and reagents, including troubleshooting and performance checks
• Processing of complex non-conformities (OOX, deviations) as well as derivation and implementation of corrections and CAPAs, including change control procedures
• Presentation and discussion of documents and technical topics to customers and authorities
• Participation in internal and cross-departmental projects as well as taking on on-call duties

Your Profile

• Completed studies (Master's) in Biotechnology, Biology, Biochemistry, or Chemistry, or an equivalent field of study – alternatively, a Bachelor's degree with at least 5 years of professional experience; a doctorate is an advantage
• At least 3 years of professional experience in the field, ideally under GMP or GLP conditions, with a wide range of analytical methods (focus on Immunoassay/ ELISA, Cell Culture, FACS)
• Sound knowledge of relevant laws and guidelines (including Gentechnikgesetz, Biostoffverordnung) as well as Excel skills beyond user level and statistical knowledge
• Good written and spoken English skills
• Conceptual and analytical competence, organizational skills, initiative, ability to cooperate, and customer orientation; no intolerances regarding laboratory work </body>